Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT01652534|
Recruitment Status : Terminated (Low enrollment)
First Posted : July 30, 2012
Last Update Posted : March 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: Amantadine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Efficacy of Amantadine for Gait Dysfunction and Gait Freezing in Patients With Parkinson's Disease|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||August 2015|
Active Comparator: Amantadine
Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day
Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).
Other Name: Symmetrel
Placebo Comparator: placebo
Other Name: Sugar Pill
- Timed Up and Go (TUG) [ Time Frame: Baseline, week 4, week 7 and week 11 ]This is a walking assessment. The subject will begin in the seated position, stand up, walk 7 meters, turn around, and sit back down. The entire process from leaving the chair to returning to the chair will be timed. Also, the Timed Up and Go (TUG) will be done both in the ON and OFF states.
- modified Timed Up and Go (mTUG) [ Time Frame: Baseline, week 4, week 7, week 11 ]The subject sits in the chair approximately 3 1/2 meters away from doorway with the door closed. Subject then stands up and walks one meter to a 40cm X 40cm box taped on the floor. Within the box the patient turns clockwise (360 degrees), then turns counterclockwise (360 degrees). Walk to open the door and walk through the doorway, turn around and return to the chair. Modified Timed Up and Go (mTUG) completed in three components including walking the course without additional tasks, carrying a tray with a cup of water, and counting backwards from 100, in both ON and OFF state.
- Analysis of Motor Functioning using the Parkinson's Home Diaries [ Time Frame: Baseline, week 4, week 7, week 11 ]Subject will record motor activity as OFF, ON (mobility improved) or asleep on the diary every half hour for two days. Subjects further define ON time according to dyskinesia categories "none", "non-troublesome" or "troublesome." The home diaries are used as an evaluation measure of the intervention by assessing the change in off time and change in on time with troublesome dyskinesia. This provides a more accurate reflection of clinical response than change in off time alone.
- Freezing of Gait Questionnaire [ Time Frame: Baseline, week 4, week 7, week 11 ]A questionnaire that is used to assess the likelihood of the subject freezing in a number of different scenarios.
- Clinical Global Impression (CGI) [ Time Frame: Baseline, week 4, week 7, week 11 ]Global Improvement is the second scale in the clinical global impression (CGI). Total overall improvement is judged by whether or not, in the judgment of the assessor, the improvement is entirely due to the drug treatment. It is also a 1-7 point weighted scale, going from "very much improved" (1) to "very much worse" (7). A zero score is assigned if the score is not assessed.
- Parkinson's Disease Questionnaire-39 (PDQ-39) [ Time Frame: Baseline, week 4, week 7, week 11 ]The Parkinson's Disease Questionnaire-39 (PDQ39) is a copyrighted instrument to assess symptoms of Parkinson's disease (PD) with 39 questions relating to mobility, activities of daily living, emotional well-being, social support, cognition, communication and bodily discomfort. The test asks subjects to rate each question regarding their Parkinson's disease symptoms over the past month.
- Gait Analysis Testing [ Time Frame: Baseline, week 4, week 7, week 11 ]Use of an accelerometer such as Motorola Droid and wireless acceleration sensors to record gait parameters step time, walking speed, and cadence during the timed up and go (TUG) and modified timed up and go (mTUG) components. The sensors will be attached to the subject's legs and trunk using Velcro straps. The accelerometer will be held or clipped onto the subject in order to measure his or her acceleration. This is done within clinic and during the visit time.
- Fatigue Severity Scale (FSS) [ Time Frame: Baseline, Week 4, Week 7, Week 11 ]A questionnaire used to discriminate between Parkinson Disease (PD) patients with fatigue and those without fatigue.
- Tolerability [ Time Frame: Baseline, Week 4, Week 7, Week 11 ]Tolerability analysis as determined by the number of subjects completing each arm of the study.
- Drug Safety and Tolerability Analysis [ Time Frame: Baseline, Week 4, Week 7, Week 11 ]Analyzing the safety of the medication, Amantadine. Data regarding the medication will be collected from the patient on each visit including any adverse events since the last visit, frequency and severity of falls. This is done in order to determine the safety of Amantadine.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652534
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Tanya Simuni, MD||Northwestern University|